Ther Adv Med Oncol: A domestic multicenter head-to-head phase III study found that the second-line FOLFIRI regimen was not superior to single-agent irinotecan therapy in patients with metastatic colorectal cancer, but increased toxicity

FOLFIRI [irinotecan, folinic acid (CF), and fluorouracil] is considered metastatic in failure of first-line XELOX/FOLFOX regimensStandard second-line chemotherapy regimens for colorectal cancer
(mCRC) patients .

However, it is unclear whether fluorouracil is still necessary in this setting

FOLFIRI [irinotecan, folinic acid (CF), and fluorouracil] is considered metastatic in failure of first-line XELOX/FOLFOX regimensStandard second-line chemotherapy regimens for colorectal cancer

The study (NCT02935764) was a randomized, multicenter, open-label, phase III clinical study conducted in five hospitals in China
.

From November 4, 2016 to January 17, 2020, patients ≥ 18 years of age with histologically proven unresectable mCRC and failure of the first-line XELOX/FOLFOX regimen were screened and enrolled

The study (NCT02935764) was a randomized, multicenter, open-label, phase III clinical study conducted in five hospitals in China

A total of 172 mCRC patients were randomized to receive FOLFIRI (n = 88) or irinotecan (IRI, n = 84)

Median PFS was 104 days (3.

Differences in PFS and OS between the two groups

Differences in PFS and OS between the two groups

The ORR of the two groups was 6.
8% and 7.
1%, respectively, which was not statistically different (p=0.
933)
.

The ORR of the two groups was 6.
8% and 7.
1%, respectively, which was not statistically different (p=0.
933)
.

The ORR of the two groups was 6.

The following adverse events (AEs) were significantly more frequent in the FOLFIRI group than in the irinotecan group: AEs of any grade included leukopenia (73.

Adverse events in both groups

Adverse events in both groups

Similarly, subgroup exploratory analysis also showed that FOLFIRI treatment was not superior to single-agent irinotecan in all subgroups
.

Similarly, subgroup exploratory analysis also showed that FOLFIRI treatment was not superior to single-agent irinotecan in all subgroups
.

Similarly, subgroup exploratory analysis also showed that FOLFIRI treatment was not superior to single-agent irinotecan in all subgroups

Subgroup analysis

Subgroup AnalysisSubgroup Analysis

In conclusion, this study is the first head-to-head study and found that for mCRC patients who failed the first-line XELOX/FOLFOX regimen, the second-line single-agent irinotecan achieved PFS, OS and ORR similar to the FOLFIRI regimen with less toxicity
.

In conclusion, this study is the first head-to-head study and found that for mCRC patients who failed the first-line XELOX/FOLFOX regimen, the second-line single-agent irinotecan achieved PFS, OS and ORR similar to the FOLFIRI regimen with less toxicity
.

The study is the first head-to-head study and found that second-line single-agent irinotecan achieved similar PFS, OS and ORR as FOLFIRI in patients with mCRC who failed first-line XELOX/FOLFOX regimens, with less toxicity

Original source:

Xiaowei Zhang, Ran Duan, Yusheng Wang, et al.

Xiaowei Zhang, Ran Duan, Yusheng Wang, et al.
FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial.
Ther Adv Med Oncol.
2022, Vol.
14: 1-12.
DOI: 10.
1177/17588359211068737.
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